From Concept to Proof of Concept   

Advinus offers a full range of chemistry services for drug development at its Bangalore center spanning gram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development. The chemistry services are provided on both fee-for-service (FFS) and full-time equivalent (FTE) basis. Advinus clients range from academic institutions to small biotech to big pharma, and also agro chemical companies.

Capabilities include:

  • Kilo-lab and pilot-plant for process development, scale-up and production of drug substance for pre-clinical studies
  • Well-equipped, QP-audited cGMP facility/capabilities to produce NCE in quantities suitable to support up to early clinical development
  • An excellent scientific team of skilled, well-trained and highly experienced synthetic organic chemists, analytical chemists, and chemical engineers to follow a regulatory-driven, phase-appropriate process development strategy to support various stages of CMC
  • Experienced scientists with deep understanding of drug discovery and development to ensure speedy and flawless execution of CMC campaigns in a cost-effective manner

Chemistry Services include:

Custom Synthesis

  • Gramto multi-kilo gram scale synthesis (non-GMP & cGMP)
  • Focused libraries for lead generation and lead optimization
  • Scaffolds, building blocks and Intermediates
  • Reference and standard compounds
  • Metabolite and impurity synthesis
  • Stable label compounds (deuterium labelled)
  • Scale up support to DMPK and Tox studies

Process Development

  • Design and demonstration of innovative and sustainable synthetic routes
  • Regulated starting materials, advanced intermediates, and specialty molecules with an emphasis on IP, cost, quality, safety, atom efficiency, and green chemistry
  • Development of original, non-infringing and environment friendly synthetic routes for commercial manufacturing of generic APIs
  • Design and development of scalable, robust, safe and cost-effective processes using systematic methodologies such as Design of Experiments (DoE) and Quality by Design (QbD),
  • Process optimization to identify critical process parameters (CPP) and to obtain optimum yields and high quality of products
  • Process validation studies to assure products meet specified quality parameters consistently and reliably
  • Identification of potential hazards such as uncontrollable exothermic reactions, explosive reactions, unexpected release of toxic or flammable gases etc., by performing careful Process Hazard Analysis/Process Safety Assessment to eliminate unsafe operations
  • Process Safety Assessment using Reaction Calorimetry (RC) and Differential Scanning Calorimetry (DSC)
  • Modern equipment, utilities, and state-of-the-art scale-up capabilities to supply drug substance for preclinical as well as for clinical studies up to Phase II in compliance with cGMP
  • Seamless technology transfer from lab to pilot-plant and to commercial plant for large-scale manufacturing
  • Polymorph screening, identification and evaluation
  • Comprehensive salt, hydrate or co-crystal screening studies
  • Synthesis of metabolites and their characterization using LC-MS/ MS and NMR spectroscopy

CMC Analytical Services

Advinus has well equipped analytical laboratories with modern and sophisticated analytical instrumentation. We offer regulatory-compliant analytical services to support CMC campaigns that includes:

  • Analytical method development and optimization as per client’s requirement or as per cGMP requirement
  • Analytical method validation as per ICH guidelines
  • Complete or partial method validations
  • Cross-validations between two laboratories

Methods are developed to carry out following analysis:

  • Reaction monitoring using HPLC, GC, LC-MS, and GC-MS
  • Purity determination by HPLC and GC
  • Assay determination by HPLC, GC, and Titrimetry
  • Chiral purity determination by HPLC
  • Residual solvents determination by headspace GC
  • Potency determination of analytical standards
  • Quantitative NMR analysis
  • Physical and chemical tests
  • Contamination carry over for project to project change over
  • Assistance in validating methods and transferring them to client’s sites and ensuring reproducibility of results
  • Advinus provides services for extended stability studies under varied  temperature and humidity factors, ideal storage conditions and testing stability of APIs to meet regulatory requirement
  • Advinus has the capability to perform accelerated or forced degradation studies for  drug substance under acidic, basic, oxidative, photo, and thermal conditions and  identify and characterize potential degradation products
  • Development of methods to isolate impurities in a drug substance, regulatory starting materials, advanced intermediates, and APIs using various techniques such as flash chromatography, liquid-liquid extractions, and preparatory HPLC.
  • Elucidation of structure of the isolated impurities using MS/LC-MS, and NMR spectroscopy.
  • Preparation of reports for regulatory submission
  • Preparation of reference/working standards of raw materials, intermediates, impurities and finished products by selecting high purity material and testing it against the available official reference/working standards.
  • Qualification of reference/working standard by performing purification and characterization of the substance, in case an official reference/working standards are unavailable